Wednesday, October 1, 2014

Onglyza® (Saxagliptin) Claims/Cases To Be Separated From Larger Incretin Mimetics MDL -- Merck's Januvia®/Janumet®

If I had to guess, I 'd say that the reason the Onglyza® claims are being set to the side is that -- at least according to FDA -- post February 2014, there is some hint that elevated risks of cardiac events may be associated with saxagliptin, but not necessarily the other incretin mimetics. At least not yet. All are DPP-4 inhibitors, but only saxagliptin seems to be in the FDA's focus, on that score, post a New England Journal of Medicine report.

So it makes reasonably good sense to keep all the similar (pancreatitis) incretin mimetic claims in one place, and handle the alleged cardiac risk claims elsewhere -- for efficiency. From the motions, then:

. . . .On September 13, 2013, Plaintiff Teresa Seufert filed Seufert v. Merck Sharp & Dohme Corp., et al., Case No. 13-cv-2169 AJB (MDD). Although that complaint included claims against Merck Sharp & Dohme Corp. that fall within the scope of claims assigned to MDL No. 2452, it also included claims against AstraZeneca Pharmaceuticals LP and Bristol-Myers Squibb Company as to Onglyza. Plaintiffs subsequently filed Gaines, Lara, and McDaniel, which like Seufert, involved claims against the MDL Defendants that fall within the scope of claims assigned to MDL No. 2452 and also contained Onglyza claims. Onglyza claims were not part of the JPML Order creating MDL No. 2452. . . .

[Merck and the other] Defendants filed the Motion [to remand] on September 16, 2014. . . .

In the Motion, Defendants seek to separate the claims against Defendants from the Onglyza cases in which they are included as parties. . . . Plaintiffs do not. . . oppose this motion. . . .

So it will almost certainly be that the saxagliptin claims portions (a January 2011 backgrounder, under that link) of these cases, some of which allege elevated risks of cardiac related event side effects (claims not generally present in the MDL for incretin mimetics), will be left out of this main Southern California federal District MDL, by a subsequent order -- granting the motion. Enjoy your. . . hump day!

Tuesday, September 30, 2014

Roche, BMS And Merck Showing Good PD-1 Immuno Data -- In Bladder Cancer Too

Again out of Madrid -- and the big cancer confab -- the Anti-PD-1 immuno-oncology candidates look promising.

Separately, BMS is in a tight race on lung cancer (graphic at right, from ASCO back in June) with AZ's combo candidates (and AZ's candidate looks a little better on the side effect profile there). We will watch that one closely. Merck is running third there, at the moment -- and that is a massive burden cancer. Here's the bladder studies update bit:

. . . .Merck & Co's Keytruda and Roche's experimental antibody MPDL3280A have both achieved durable responses in patients with advanced bladder cancer, raising hopes of the first new therapy for the aggressive disease in more than 30 years. . . .

Data from early stage trials reported at the European Society of Medical Oncology (ESMO) conference in Madrid this week reveal that Keytruda (pembrolizumab) and MPDL3280A - both of which act on the programmed death-1 (PD1/PDL1) pathway - have encouraging activity in advanced urothelial cancer.

A phase Ib trial of Keytruda revealed that as a monotherapy the drug achieved a 24% overall response rate in patients with PDL1-positive tumours, with three of the 29 patients in the small study achieved a complete response. At the time of analysis, patients had shown responses of between 16 and 40-plus weeks. . . .

Very encouraging! And the big picture here is that we are taking major strides -- against largely intractable cancers. Heady stuff, indeed.

Sunday, September 28, 2014

Another Cancer Shows Good Responses -- To Merck's Keytruda® (Pembrolizumab/Lambrolizumab)

This morning, yet another cancer has shown solid response rates, on pembrolizumab, in a very small study.

And that is good news for Whitehouse Station. We all wait on the bigger burden cancers, to see which of BMS's Opdivo® or Merck's Keytruda® reaches market first, but in the mean time, this is immaterially good news. At this same European oncology conference in Madrid, Spain, Merck expects to show some data on five other types of cancers, in the coming week -- and some of that data might turn out to be material. We will watch for it. From a NASDAQ wire source, then:

. . . .The early findings presented showed an overall response rate of 31 percent with KEYTRUDA as monotherapy. In a small Phase I study involving 39 patients with PD-L1 positive, advanced stomach cancer, a total of 12 people showed tumor shrinkage after being given Keytruda. . . .

These data, from a cohort of the ongoing Phase 1b KEYNOTE-012 study, were presented today, as part of a late-breaking oral session, by Dr. Kei Muro, Aichi Cancer Center Hospital, Nagoya, Japan, at the European Society for Medical Oncology 2014 Congress in Madrid, Spain. Data investigating the use of KEYTRUDA monotherapy in five tumor types will be presented at ESMO 2014. . . .

It turns out that almost three quarters of all of these types of cases of stomach cancers appear in the developing world. And so, this won't likely be as lucrative a market franchise as some of the others, for immuno-oncology treatments. Which may help explain why this program is still in Phase I, while lung cancer is much futher along -- both at Merck, and at BMS. Enjoy the sunshine and cooler air. . . I will.

Saturday, September 27, 2014

ENHANCE Vytorin® Securities Litigation Claimants Should See Checks Before Christmas -- Thanks ($688 Million Worth!), Fred Hassan!

The sad thing is that a competent Chairman and CEO -- any competent one -- would have saved this $688 million, and might have avoided having to merge into Merck (under significant duress), altogether. [And, over $116 million in plaintiffs' attorneys' fees as well. Perhaps double that, in defense fees. Ugh.]

So in a very real sense, this $688 million is being taken from the Merck shareholders' pockets (and their insurers), due to the acts and omissions of the ex-Schering-Plough top six executives (Hassan, Cox, Sabatino and Saunders, et al.), and board of directors -- relative to the delays in releasing the (Vytorin®) ENHANCE study results.

Here's a bit of the latest motion for a dispositive order, from Friday:

. . . .PLEASE TAKE NOTICE that on October 20, 2014, at 10:00 a.m. or as soon thereafter as counsel may be heard, the undersigned counsel for Lead Plaintiffs shall move before the Hon. Esther Salas, U.S.D.J. at the Martin Luther King Building & U.S. Courthouse, 50 Walnut Street, Newark, New Jersey 07101 for entry of the accompanying Order Approving Distribution Plan, which will, inter alia:

. . .direct the distribution of the Net Settlement Fund to Claimants whose Claims have been accepted as valid and approved by the Court, while maintaining a Reserve for any contingencies that may arise; (iii) direct that distribution checks state that the check must be cashed within 90 days after the issue date; (iv) direct that Authorized Claimants will forfeit all recovery from the Settlement if they fail to cash their distribution checks in a timely manner; (v) adopt the recommended plan for any funds remaining following the Initial Distribution; (vi) release claims related to the claims administration process; (vii) approve Epiq’s fees and expenses incurred from October 1, 2013 through May 31, 2014, and to be incurred in connection with the initial distribution of the Net Settlement Fund; (viii) authorize the destruction of Proofs of Claim and supporting documents after the second distribution of the Net Settlement Fund; and (ix) provide that the Court retains jurisdiction to consider any further applications concerning the administration of the Settlement, and such other and further relief as the Court deems appropriate. . . .

We will let you know what comes of the October 20 hearing. But I would expect checks before Thanksgiving, even, this year.

Scheduling Miscellany -- Q3 2014 Results Call: Pre-Market Open, On October 27, 2014

It has been a very slow couple of weeks for Merck news -- at least the US Merck. The German one has announced a mega merger. But too many news outlets have confused the two. No -- this Merck & Co. has run sub-rosa for a bit.

So. . . its next big pre-scheduled event? The Q3 2014 earnings call, on the morning of October 27, 2014. On it, we may get a sense of the uptake on Keytruda® -- even if for only the last few days, in the quarter:

. . . .Merck will hold its third-quarter 2014 sales and earnings conference call with institutional investors and analysts at 8:00 a.m. EDT on Monday, Oct. 27. During the call, company executives will provide an overview of Merck’s performance for the quarter.

Investors, journalists and the general public may access a live audio webcast of the call on Merck’s website. . . .

We will tune in on that morning.

Friday, September 26, 2014

We May Learn More -- On Mediation Progress -- By October 8, In Fosamax® Femur Fracture Cases

With motions to dismiss the largest bulk of these cases already pending, and mediation underway, the able Judge Joel Pisano, in the New Jersey federal District Courts of Trenton, has set an update conference, in person, for counsel, on the morning of October 8.

We may well learn about the progress -- of the mediation -- on that day. From the order then:

. . . .ATTENTION COUNSEL: An in-person status conference has been set for October 8, 2014 at 11:00 AM in Trenton - Courtroom 1, before Judge Joel A. Pisano.

The following parties are directed to be present: Steve Marshall, counsel for Merck, and Plaintiffs counsel who can speak to the mediation and Merck's pending motion for an Order to Show Cause. . . . Matter has been confirmed. . . .

So it goes. Happy Friday, one and all! Enjoy the day's sunshine -- I know I will.

Thursday, September 25, 2014

Come January 2015, Merck May See Declines In Remicade®/Simponi® Franchise Growth Rate: NICE Proposal

Between now and then, each local level UK reimbursement authority will continue to adhere to its own reimbursement policies regarding the pair. After the NICE proposal becomes final, though, the pressure on reimbursement will be locked in, in England, and spread across the channel, in all likelyhood -- and ultimately lead to reimbursement levels more deeply curtailed -- for the duo, across the EU. As goes the UK, so goes EU -- quite commonly, in these matters. . . eventually.

Recall that Merck's single largest retained geography on this franchise is the United Kingdom and the EU, after the settlement of the J&J arbitration (with the termination fight occasioned by the S-P reverse merger). We shall see, but it would seem that the past year's impressive growth in the Simponi®/Remicade® revenue stream (driven largely by EU growth) may be drawing to a gradual close. Here is PM Live! on it all:

. . . .In draft guidance the Institute says [Merck's] Remicade (Infliximab) and Simponi (golimumab), and AbbVie's Humira adalimumab) have not been proven to be more cost effective than current available treatments.[Ed. Note: Those being "biosimilars" (essentially generic biological agents) -- approved last summer -- and made by Celltrion, and Hospira.]

This is despite MSD agreeing a patient access scheme with the Department of Health to make a 100 mg dose of Simponi (which costs £1,525.94) available to the NHS at the same cost as the 50 mg dose (£762.97).

Including the patient access scheme and assuming the recommended dosage is followed, the cost of Simponi induction therapy is £2,289 and its monthly cost for maintenance therapy is £763.

Meanwhile, the cost of Remicade induction therapy at its recommended dose is £5,035 and the monthly cost of maintenance therapy is £210 and induction therapy with Humira costs £2,113 and it has a monthly cost for maintenance therapy of £704. . . .

Obviously, the EU biosimilar approvals of last year (see archive graphic, at right) are taking hold in the minds of the reimbursement crowd in the United Kingdom, and soon -- the EU, I predict. Do stay tuned.

Wednesday, September 24, 2014

Good For Consumers; Good For Pharma: More Insurers; More Coverage -- In 2015 Under Obamacare

Ahem. The facts. . . matter.

And the facts. . . include these: Obamacare has improved competition in the health insurance marketplace, in the United States. That helps consumers.

And the broader pool of insured people -- nationwide -- adds to the money pharma (big and small) may collect for their life saving wares. This is what those Tea Partiers so desperately feared: A potentially healthier America, at a lower overall system wide cost? Seriously. Dude. Seriously?!

Via the Gray Lady overnight, then-- a bit (but do go read it all):

. . . .Consumers in much of the country will have a broader selection of health insurance plans next year, the Obama administration said Tuesday, as it predicted an increase of about 25 percent in the number of insurers that are expected to compete in federal and state marketplaces.

More competition will help hold down premiums, federal health officials said. The administration released preliminary data on insurers that have indicated they want to participate next year in the insurance exchanges, where the federal government subsidizes premiums for millions of people. So far, it said, the number of insurers, also known as issuers, is up to 315 next year, from 252 this year. For the 36 states served by the federal marketplace, it said, the number is up almost 30 percent, to 248 next year, from 191 this year.

Fourteen states ran their own exchanges, and half have reported the number of insurers expected in 2015. The number in these states and the District of Columbia is expected to increase by about 10 percent, to 67, from 61, the administration said. . . .

We will keep you apprised, but this is -- to the letter -- as I've said all along, since 2010. [Slow Merck news week.]

Monday, September 22, 2014

Roger Pomerantz -- What's He Up To, These Days?

Tonight we update the readers -- on yet another Ex-Merckie. This time, it is Roger Pomerantz. He now serves as a senior partner at a venture fund called Flagship Ventures. In that role, he also acts as chairman, president and CEO of Seres Health, a company in which Flagship has a stake. We just learned that Dr. Pomerantz has also added the chairmanship of the scientific advisory board of privately-held Novira Therapeutics -- to his list of avocations, post-Whitehouse Station.

Here's the bit -- from local sources:

. . . .Novira Therapeutics Inc., Doylestown, a privately held biopharmaceutical company developing novel therapies for curative treatment of chronic hepatitis B virus infection, has named Roger J. Pomerantz chair of its scientific advisory board. In this role, he also will function as a senior adviser to the company. Pomerantz is president, chief executive officer, and chairman of Seres Health and was senior vice president and worldwide head of licensing and acquisitions at Merck & Co. Inc., where he oversaw all licensing and acquisitions at Merck Research Laboratories. . . .

So it goes -- he's a very talented guy.

Also Last Week: Plaque Psoriasis Phase III Development License, With Sun Pharma

You (regular readers) will likely recall that Sun is Merck's partner of choice in India, at least to make authorized generic versions of sitagliptin (since April 2013 -- you know it as Januvia®/Janumet®). So, it makes sense that Whitehouse Station would partner up -- on this smallish local India market license candidate, called tildrakizumab. Plaque Psoriasis is a reasonably large global market opportunity. Nothing like the "big burden" cancers -- but a good market. SO it goes, whilst I was off the grid.

From the Economic Times (London -- but India section), then:

. . . .Tildrakizumab is being evaluated in Phase III registration trials for the treatment of chronic plaque psoriasis, a skin ailment.

"Merck will continue all clinical development and regulatory activities, which will be funded by Sun Pharma. Upon product approval, Sun Pharma will be responsible for regulatory activities, including subsequent submissions, pharmacovigilance, post approval studies, manufacturing and commercialisation of the approved product," it added.

Merck is eligible to receive undisclosed payments associated with regulatory (including product approval) and sales milestones, as well as tiered royalties ranging from mid-single digit through "teen percentage" rates on sales, the joint statement said. . . .

Beyond those very wide guardrails, there wasn't any more granularity on the economic terms. Stay tuned.

Sunday, September 21, 2014

No "Source Documents" For The Moment: Incretin Mimetics MDL -- In Federal Dist. Ct., Southern California

My apologies. I've been away -- for reasons. . . immaterial to the readership.

But I'm back. And while I was out last week, the very able Judge Anthony J. Battaglia, in the federal trial level courthouse, sitting in the Southern District of California, ruled that the so-called adverse event report "source documents" need not be disclosed to the plaintiffs, at this stage of the pleadings. Here is the most recent backgrounder we've written on it all. And, below is the salient portion of an order dated September 10, 2014-- filed a few days later.

. . . .Further, the Court finds Defendants’ responses are sufficient given the limited scope of discovery previously set by the Court, and in particular the over broad scope of Interrogatory 26. . . .

So it goes. A more fullsome backgrounder is here, from about a month ago.

Tuesday, September 16, 2014

Sign Of The Times: Merck Ought To Take Heed -- Low Cost Producer Licensing In India

With the extremely high burden of Hep C as a disease in India, it seemed only a matter of time before -- either through the mechanism of the DOHA Declaration (in international proceedings), the Indian patent courts, the Ministries of Health in country or otherwise, a life saving drug like Sovaldi® would be made more affordably in India. It will now appear in low cost authorized generic form, in over 90 countries around the globe. It is already there, in Egypt (March 2014). [This development will dampen only marginally the patent fights' income potential, however. That vast trove of money is generated in the post industrial Western world primarily.]

This has as much to do with the high price of it -- as it does to do with the fact that it is effectively a cure for Hep C. And more people in India suffer from Hep C than in any single country on the planet. Even so, the price is unlikely to fall to the under $90 per regiment price that WHO experts estimate would put it in the hands of most of the world's poorest Hep C patients. From the Irish Times then:

. . . .Gilead Sciences will allow seven large Indian generic drug producers to make and sell its blockbuster hepatitis C drug Sovaldi in more than 90 developing countries, in a move it says will ensure affordable access to the potentially life-saving treatment.

The deal with companies including Cipla and Ranbaxy Laboratories follows months of fierce debate over the price of Sovaldi, which has been hailed as the biggest breakthrough in treatment for hepatitis C since the virus was discovered in 1989. . . .

The object lesson here is glaringly obvious: Merck should be prepared for similar pressures in India, as Keytruda® becomes available for more strains of cancers. India's cancer burden is unimaginably vast. So, India ministers will feel strong pressure to license, even on a compulsory basis, a bio-similar at some point. Stay tuned. The same applies to BMS -- and nivolumab. Just my $0.02. [Should be yours, too -- heh.]

Monday, September 15, 2014

Additional FDA Filing Date Delays, For Merck's Odanacatib -- As Safety Signals Seem To Appear

Once again, the next gen Merck osteoporosis candidate has been run aground, and run aground -- hard. Now a mid 2015 FDA filing may be a stretch -- and peak sales may come in under $300 million a year. Ouch.

here is our February 2013 background piece on the program.

John Carroll is chief among the smart folks over at FierceBiotech -- and he has a nice, pithy analysis of the data, and consequent additional delays up:

. . . .[T]here was also evidence of a troubling side effect profile that could well damage Merck's prospects. There was a slight increase in the risk of atrial fibrillation as well as more strokes in the odanacatib crowd. A total of 109 patients (1.4%) had a stroke in the drug arm, compared to 89 (1.1%) in the placebo arm.

Cardiovascular side effects are going to attract careful regulatory attention. More morphea-like skin lesions and atypical femoral shaft fractures were also reported for 5 patients in the odanacatib group with none in the placebo group. And Merck--which had been expected to file before the end of this year---says it will now delay its FDA submission until next year after it gathers more data.. . .

We will keep the readership posted.

Tough breaks -- rather literally.

Why "Adverse Event" Source Documents Matter, In Discovery Of Incretin Mimetics Litigation

Incretin mimetics, like Merck's Januvia® (sitagliptin), and those made and sold by several other manufacturers, are the subject of some consolidated federal MDL action in Southern California.

We've begun tracking this narrative, as of relatively recently. [Backgrounder of two weeks ago, there.]

The plaintiffs are angling to get the origial source documents (AERs), or copies of them -- of the hundreds of adverse event reports -- from Merck and the others. The plaintiffs need them they say to establish causation, as to their claims (increased risk of pancreatitis and possibly, risks of some kinds of cancers). Put succinctly, a summary of the document may look ordinary, while the source itself may reveal patterns not apparent in the very same summaries. So, here is a bit of the plaintiffs' latest motion, and argument -- for discovery and production of the source files:

. . . .Source files are important for many reasons. They show what actually happened with an adverse event. It is not uncommon for MedWatch summaries to mischaracterize or misstate important aspects of an event. For instance, a manufacturer’s MedWatch summary may say an event was not causally related to its drug, when the source documents (e.g., medical records) show the doctors felt the event was caused by the drug. The only way to tell if the MedWatch forms given to the FDA accurately characterize an adverse event is to review the source files for that event. . . .

Source files also show whether pancreatic cancers were properly reported to the FDA. There are reasons to believe such cancers were not correctly reported, and were underreported. . . .

These questions can only be answered by reviewing the source documents for each pancreatic cancer adverse event. Source files also show whether pancreatic cancers were properly reported to the FDA. . . .

Source files can also show whether "safety signals" have been generated. FDA guidance notes that even one "well-documented" adverse event can be a safety signal. Source files can provide the detailed documentation for those signals. . . . Signal detection leads directly to the assessment of causal association. . . .

Finally, source documents are also necessarily part of Defendants’ preemption defense. To establish that defense, Defendants must prove by "clear evidence" that the FDA would reject any [additional warnings] that fully explained the basis for the proposed warning. . . .

We will keep you posted, but remember, these are the plaintiffs' arguments. Merck would say all the info the plaintiffs need is already available in a summarized fashion, at MedWatch. Have a peaceful and productive start to the week!

Sunday, September 14, 2014

Q.: Is A 10 Per Cent Max. "Sales" Bonus Opportunity Going To Be Adequate -- To Sell Keytruda® -- In Melanoma?

At the outset, I'll suggest that this sales compensation incentive plan decision may well have been driven in large part -- by the compliance folks at Merck -- being appropriately conservative. [More on that, in the final paragraph after the pull-quote.] To the story, then:

One of our erstwhile anonymous commenters below asks an excellent question -- and I will take it as being an accurate characterization of Merck's current sales incentive plan, as the very same predicate facts have been discussed over at CafePharma during the last 60 or so hours.

Our commenter reports that Merck is only offering a maximum of 110 per cent normal sales bonus opportunity to the oncology reps selling Keytruda® -- at least on this initial narrow "non-responder" melanoma patient FDA approval, in the US. As my graphic would suggest, I think the monoclonal antibody largely sells itself (just lay out the clinical trial results to date). Moreover, it is (until BMS's Opdivo® [nivolumab] clears, here in the US) a monopoly product. Yep -- as a breakthrough -- hard to see how the biologic won't sell itself. And then I'd note that perhaps only 1,500 patients meet the current indicated protocol. No need to "beat the bushes" to find them. Their doctors will find Merck, and pronto. The are all facing very dire prognoses without Keytruda.

. . . .Anonymous said. . .

So the sales plan incentives for the program were announced internally today. The top of the heap 10% in sales max out at 110% of target. It looks like management is convinced this one will sell itself.

Another huge mistake.

September 12, 2014 at 10:53 PM. . . .

It may be -- I guess we shall see, when BMS prices and rolls out its incentives plan, relative to its Opdivo® (nivolumab) melanoma launch, here in the US, later this year. [Does anyone know how BMS has handled this -- as it launched -- in Japan, back in mid-summer 2014?]

In closing, I will observe that the LAST thing Whitehouse Station wants to deal with, in relation to its single best hope for a "turnaround" drug/biologic francheise, in oncology. . . is an enforcement proceeding/cease and desist order from FDA/DoJ/FTC. The compliance folks likely argued that -- a too generous maximum initial bonus opportunity might encourage the Merck reps in the field to actively promote to oncologist/prescribers "off-label". I think that mindset explains about 60 per cent of the "why" behind this initial sales compensation plan. Just my $0.02. Have a peaceful, sunny and joy-filled Sunday -- to one and all, of good will.

Thursday, September 11, 2014

BMO Capital Markets Moved Merck To $64, Last Friday -- From $62

I suspect that BMO is now more sanguine about a good strong mega blockbuster showing (i.e., $3 billion to $4 billion a year), beginning two years from now -- over those next three years, from Keytruda®.

A bit then:

. . . .Merck had its price target upped by BMO Capital Markets from $62.00 to $64.00 in a research note issued to investors on Friday.

Shares of Merck & Co. opened at 61.05 on Friday. Merck & Co. has a 52-week low of $44.62 and a 52-week high of $61.33. The stock has a 50-day moving average of $58.4 and a 200-day moving average of $57.42. The company has a market cap of $176.1 billion and a price-to-earnings ratio of 32.23. Merck & Co. also was the recipient of a significant decrease in short interest in the month of August. As of August 15th, there was short interest totalling 27,776,659 shares, a decrease of 17.1% from the July 31st total of 33,501,461 shares. Based on an average daily trading volume, of 8,604,040 shares, the days-to-cover ratio is presently 3.2 days. Currently, 1.0% of the company’s shares are short sold. . . .

So it goes -- and falling short interest is a bullish sign. . . but I'd bet BMS will handily outpace Merck in immuno-oncology sales, over the next three to five years. And because BMS is smaller than Merck, that sales ramp will show itself, in a more pronounced fashion, in BMS's stock price. Just my $0.02.

Wednesday, September 10, 2014

Chairman & CEO Actually ADDS About 3,000 Shares -- Via His Cashless Exercises Reported Today

Some of the minor MSM outlets are reporting it as a net sale -- of some 9,000 shares. An "unloading". Sheesh.

But, in actuality, he has increased his holdings by about 3,000 shares -- bringing his total held as calculated for '34 Act Section 16 purposes to around 338,000 shares.

And, the trigger was pursuant to a pre-arranged plan over which he no longer exercises any discretionary timing control.

So nearly nothing may be inferred from today's SEC Form 4.

Tuesday, September 9, 2014

Some More Color -- On the Keytruda® (f/k/a Lambrolizumab/ Now Pembrolizumab) Launch. . .

Very little of any moment was said at the Manhattan Morgan Stanley Global Health Care presetntation this morning.

However, I thought I'd offer this bit of additional color -- on the launch of what used to be called lambrolizumab -- for the readership. Now branded as Keytruda® -- from a bit of Merck's own edited transcript, then:

. . . .Morgan Stanley Analyst David Risinger: Maybe you could speak to -- and this is really a question for any of you -- but maybe you could speak to how investors should think about the launch of pembro. Obviously, there will be a lot of demand for it off label for which Merck won't promote or discuss, but it would seem like the super wealthy in the country with a variety of cancers would be interested in accessing pembro now that it's going to be commercially available this month. So maybe you could talk about the commercialization strategies, the launch plans and how you manage that. . . .

Adam Schecter, EVP Merck:

. . .So obviously, we are very excited about the commercialization of Keytruda. We received our first orders yesterday and we are shipping today so the product should be available sometime this week. So that is a big moment for us to have the product available so quickly after the approval. We have our salesforce in place. We have a global oncology business unit, as Ken mentioned. In the US specifically, our salesforce is being trained as we speak and they will begin to call on physicians that treat melanoma patients in the very near future. . . .

At the same time, we are going to focus on the indication that we have, which is for utilization after failure on other products for melanoma. If you look, there is about 10,000 patients with metastatic melanoma that are treated every year in the United States. About 5,000 of them are treated on Yervoy first. The other 5,000 usually get a BRAF inhibitor. If you then look at the number of patients available based on our indication for Keytruda, we figure there's about 300 to 350 patients that will be available per month based upon the flow of patients that will fail on either the two pathways for our indication. We think there is somewhere between 1,000 and 1,500 patients that are currently available in the marketplace based upon previous failures. . . .

So although the indication is relatively restrictive and small and that is where we will focus our promotion and only where we will focus our promotion, we do realize, as you said, that there are physicians that will utilize the product off-label. We won't promote that, but we realize that that is the reality of what occurs. From a manufacturing perspective, we have a significant amount of supply. Whatever happens in the marketplace, we believe we'll be able to manufacture and supply immediately, but our focus will be on the indication that we have. But we have reimbursement support lines up and running already. We have everything ready to launch and we are in the middle of it as we speak. . . .

So it goes -- but Merck admits, as I noted many months ago (January of 2014, in fact) -- the initial FDA approved indication is pretty darn narrow. Under 1,000 patients overall. And Merck cannot lawfully chase off-label 'scrips. Add to this, that BMS is well ahead in lung study submission timeline -- with Opdivo® (Nivolumab). A great horse race, indeed!

Monday, September 8, 2014

Late-Breaking Appearance At Morgan Stanley Global Health Care Conference: Tomorrow -- Before NYSE Opens

Merck Chairman Kenneth C. Frazier -- and his team -- will present in NYC tomorrow at 8 AM Eastern.

I'll let the readership know if something material develops -- but I don't think that outcome is likely. Here's tonight's presser:

. . . .Merck announced today that Kenneth C. Frazier chairman and chief executive officer; Adam H. Schechter executive vice president and president Global Human Health; and Dr. Roy Baynes senior vice president Clinical Development Merck Research Laboratories are scheduled to participate at the Morgan Stanley Global Healthcare Conference in New York on Sept. 9 2014 at 8:00 a.m. EDT. Investors analysts members of the media and the general public are invited to listen to live audio presentation (reg. req.) of the webcasts. . . .

We will check in on it, time permitting.

Sunday, September 7, 2014

Merck To Face Trials? -- In False Claim Act Suit, And Qui Tam Suit -- On Mumps Vaccine Sold To US Government

This narrative properly begins... a few years back (in my estimation) -- in December of 2010, when Merck quietly ceased production of its individual mumps vacine (I think we were the only outlet to cover this, in real time) -- in favor of a combo MMR II vaccine array.

I now wonder if these below (alleged) problems were part of why the solo mumps vaccine program with the government was moth-balled -- in favor of a more economical (in terms of overall cost to immunize) and efficacious three way vaccine. We will never know, but on Friday Merck learned that it will have to put on a defense against claims it falsely inflated its efficacy claims for the mumps vaccine -- in order to secure a more fullsome federal reimbursement -- of the jab. On its face,that makes out a False Claims Act violation, and possibly a qui tam one, as well -- for the people who blew the whistle on it all. I suppose Whitehouse Station could settle, by paying money -- but I'd not hold my breath, there.

From the Friday article in Law 360o, then a bit [followed by my own edits and a bit of the opinions, from the pen of the very-able federal District Court Judge Jones]:

. . . .Two lawsuits accusing Merck & Co. Inc. of lying about the efficacy of its mumps inoculation in order to keep competitors from bringing their own versions of the vaccine to market will move forward, after a Pennsylvania federal judge ruled in favor of whistleblowers and direct purchasers Thursday. U.S. District Judge C. Darnell Jones II ruled that the whistleblowers had sufficiently pled that Merck might have provided false statements to the government and that the direct purchasers had shown enough evidence to establish that these falsehoods may have caused the government to overpay for the vaccine. . . .

[Specifically, as the order and opinion (42 page PDF file) of Judge Jones relates:] Defendant [Merck] allegedly told Relators that the “objective”of this new methodology was to “[i]dentify a mumps neutralization assay format. . . that permits measurement of a ≥ 95% seroconversion rate in MMR®II vaccines.” Defendant continued to test the vaccine against the virus strain that originated the vaccine. In addition, Defendant added animal antibodies to pre and post vaccinated blood samples. Relators allege that this addition was “for the singular purpose of altering the outcome of the test by boosting the amount of virus neutralization counted in the lab.” Relators claim that the use of animal antibodies created a high number of pre-vaccinated positive results, which Defendant systemically destroyed or falsified in order to legitimize the use of animal antibodies. Relators also allege that senior management was aware, complicit, and in charge of this testing. . . .

Relators reported these alleged infractions to the FDA, leading to an FDA visit. After the FDA visit, Relators were barred from participating in the mumps vaccine testing. Relators assert that Defendant continued to make the false representations of its inflated 95 percent efficacy rate to the government, while deliberately covering up the results of the tests showing a diminished efficacy. . . .

[Plaintiffs based their Complaint on the qui tam action filed by the Relators.] Plaintiffs’ theory is that because the vaccine’s efficacy was diminished, the vaccine was mislabeled and was not the product for which the government paid. As such, Plaintiffs allege that Defendant knowingly presented a fraudulent claim for payment to the U.S. government in violation of 31 U.S.C. § 3729(a)(1)(A).

Second, Plaintiffs allege that Defendant falsified, abandoned, and manipulated testing data that should have been shared with the government in order to fraudulently mislead the government into purchasing the mumps vaccine. (Dkt. No. 12 ¶ 155.) As such, Plaintiffs allege that Defendant knowingly incorporated falsified records material to their fraudulent claims for payment for the vaccine. 31 U.S.C. § 3729(a)(1)(B). . . .

Given that this Court must construe the Complaint in the light most favorable to the plaintiff, construe the CFA liberally, and approach motions to dismiss “with hesitation,” this Court finds that Plaintiffs have adequately pleaded a claim under the CFA. . . .

The court rejects Defendant’s argument that Plaintiffs’ surviving state claims are preempted by Federal law, and finds that Plaintiffs have adequately stated claims under the consumer protection statutes of New York and New Jersey. However, the Court finds that Plaintiffs have failed to state claims for breach of contract and unjust enrichment. Thus, the Court dismisses Count II, except for claims brought under the NYDAPA and the NJCFA; and, dismisses Count III, Count IV, Count V, and Count VI in their entireties. . . .

So this means that the very capable Judge Jones has ruled that Merck cannot dismiss these allegations summarily. Merck must now move forward -- to articulate legal defenses -- against these allegations. If the relators and plaintiffs prove at trial what they've alleged above, that would be enough to make it past a motion for summary judgment, and ultimately get to the jury. We will watch these suits, for the readership, going forward. Have a wonder-filled sunny late summer Sunday, one and all! I know I will.